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November 14, 2018

Implications of Medicare Coverage for Magnetic Resonance Imaging in Patients With Capped or Epicardial Leads

Author Affiliations
  • 1The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
  • 2The Greenwall Foundation, New York, New York
  • 3University of California, San Francisco
  • 4Scripps Research Institute, La Jolla, California
JAMA Cardiol. Published online November 14, 2018. doi:10.1001/jamacardio.2018.3820

The Centers for Medicare and Medicaid Services (CMS) are required to cover medical services deemed reasonable and necessary for its beneficiaries.1 While most services are covered without controversy, a small fraction receive additional scrutiny, formalized in national coverage decisions that dictate the terms of coverage for services considered to be particularly important. Some novel treatments require enrollment in a research study intended to generate evidence specific to patients receiving Medicare benefits, a process known as coverage with evidence development (CED).2 However, recent decision making by CMS calls into question the application of the CED pathway for patients with pacemakers or implantable cardioverter-defibrillators (ICDs) who require magnetic resonance imaging (MRI). We argue that current CMS policy for patients with capped or epicardial leads needlessly restricts access to potentially life-changing treatment, while also limiting investigators’ ability to gather further evidence for clinical care and Medicare coverage.

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